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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68941

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 24, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Wockhardt Usa Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA

D-1541-2014
Recall number
D-1541-2014
Initiated
July 24, 2014
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
11,661 HDPE bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.

Code information

Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15

Distribution pattern

Nationwide